DeviceClearance

Product code QEJ— Gastroenterology, Urology

DuraGraft

Classification name
Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
Device class
Class 2
Regulation
21 CFR 876.4100
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

“A flushing and storage solution for vascular autografts is a device that is used for flushing or short-term storage of vascular grafts. This generic type of device is intended to maintain cell viability and structural integrity of vascular grafts during short-term storage at room temperature during the surgical procedure.”

— U.S. Food and Drug Administration, device classification record for product code QEJ under 21 CFR 876.4100, via openFDA

Market context for product code QEJ

FDA has cleared 2 devices under product code QEJ between 2023 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QEJ

Recent clearances under product code QEJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.